PATH Seeks To Gain FDA Approval Of Redesigned Female Condom

The New York Times on Tuesday examined the global health group PATH's efforts to gain approval of its redesigned female condom. According to the Times,the female condom has never been widely used in the U.S. and never"caught on" in developing countries, where "public health workers hopedit would ... empower women and stop the AIDS epidemic in its tracks"when it was introduced in the late 1990s. About 12 million femalecondoms are delivered annually in developing countries, compared withabout six billion male condoms, according to the Times.

PATHhopes its redesigned female condom, which is made of soft, thinpolyurethane, will "succeed where its predecessor failed." Theredesigned female condom is easier to insert than the older version,and it has dots of adhesive foam that adhere to the vaginal wall andexpand during sex. According to PATH, 90% of couples in Mexico,Seattle, South Africa and Thailand who tested prototypes of the newfemale condom were satisfied with the new version's comfort and ease ofuse. In addition, 98% of the couples said sex with the new version was"O.K. to very satisfactory."

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PATH is now seeking FDAapproval for the female condom so it can be sold in the U.S., whichwould make it easier to license in developing countries and achieve anendorsement from the World Health Organization.The condom must go through clinical trials, which are expected to cost$3 million to $6 million, before it can be approved, the Times reports.

MichaelFree, head of technology at PATH, said the clinical trials will be a"huge impediment ... because no one's willing to put up that sort ofmoney." USAID, the Bill & Melinda Gates Foundation, the Lemelson Foundation and other groups contributed to the development of the new condom but are unwilling to cover the cost of trials, the Times reports.

Background

Peter Piot, executive director of UNAIDS, said that the use of female condoms "has remained frustratingly and tragically low."

Lois Chingandu -- director of SAfaids,an HIV/AIDS organization in Zimbabwe -- said women generally do notwant their husbands to know they use female condoms because condom useoften is considered a sign of infidelity and could lead to violence. Inaddition, a lack of marketing and training also contributed to thefemale condom's failure, according to Mitchell Warren, who promoted thefemale condom when it was first introduced (McNeil, New York Times, 11/13).